Company (Location) |
Product |
Description |
Indication |
Status |
Date |
Abbott (Abbott Park, Ill.) |
Humira |
Adalimumab |
Severe axial spondyloarthritis |
European Commission approved it for patients who have no X-ray evidence of structural damage |
7/31/12 |
Almirall SA (Barcelona, Spain) |
Eklira/Bretaris Genuair |
Aclidinium 322 mcg twice daily |
Chronic obstructive pulmonary disease |
European Commission granted marketing approval |
7/26/12 |
Bayer HealthCare Pharmaceuticals Inc. (Wayne, N.J.; subsidiary of Bayer AG) |
BAY94-9027 |
Prophylactic and on-demand treatment |
Hemophilia A |
Began enrolling patients in an international Phase II/III trial |
7/10/12 |
Bristol-Myers Squibb Co. (New York) |
Brivanib |
Kinase inhibitor |
Liver cancer |
Did not meet its primary overall survival objective based on a noninferiority statistical design in the Phase III trial |
7/23/12 |
Bristol-Myers Squibb Co. (New York) and AstraZeneca plc (London) |
Onglyza |
Saxagliptin |
Type II diabetes |
Phase III results demonstrated improvements across key measures of blood sugar control compared to placebo |
|
Eisai Inc. (Woodcliff Lake, N.J.) |
Fycompa |
Perampanel |
Partial-onset seizures |
Phase III data showed that once-daily perampanel 8 mg or 12 mg improved seizure control, and that both doses were safe and well tolerated; European Commission issued marketing approval |
7/27/12 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Zonegran |
Zonisamide |
Epilepsy |
European Medicines Agency approved an MAA to extend the use from adjunctive therapy to also include monotherapy for treating partial seizures |
7/5/12 |
Eli Lilly and Co. (Indianapolis) |
mGlu2/3 |
Pomaglumetad methionil |
Schizophrenia |
Negative results showed the drug did not separate from placebo in the primary efficacy endpoint |
7/12/12 |
Eli Lilly and Co. (Indianapolis) and Bristol-Myers Squibb Co. (New York) |
Erbitux |
Cetuximab |
Newly diagnosed metastatic colorectal cancer |
Gained FDA approval when used in combination with Folfiri |
7/10/12 |
Eli Lilly and Co. (Indianapolis) |
Jentadueto |
Linagliptin/metformin hydrochloride |
Type II diabetes |
European Commission granted marketing authorization |
7/26/12 |
GlaxoSmithKline plc (London) |
Vaccine |
Contains the QS-21 Stimulon 1 adjuvant by Agenus Inc. |
Herpes zoster (shingles) |
Began a Phase III trial |
7/19/12 |
Grifols SA (Barcelona, Spain) |
Alpha1-proteinase inhibitor |
Inhaled formulation |
Cystic fibrosis |
Plans to start a safety trial later this year |
7/18/12 |
Janssen Biotech Inc. (Horsham, Pa.; unit of Johnson & Johnson) |
Simponi |
Golimumab; a subcutaneously administered antitumor necrosis factor-alpha therapy |
Moderately to severely active ulcerative colitis |
Submitted a supplemental BLA to the FDA and a Type II variation to the EMA requesting approval in those who have had an inadequate response to conventional therapy |
7/18/12 |
Janssen Research & Development LLC (Raritan, N.J.) |
TMC207 |
Bedaquiline |
Tuberculosis |
Submitted an NDA |
7/3/12 |
Kowa Pharmaceuticals America Inc. (Montgomery, Ala.) and Eli Lilly and Co. (Indianapolis) |
Livalo and Prezista/Norvir |
Pitavastatin 4 mg and protease inhibitor combo (darunavir/ritonavir) |
AIDS |
A pharmacokinetic study found that, when co-administered, the blood levels for Livalo and each of the protease inhibitors were not significantly affected |
7/24/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Isentress |
Raltegravir |
HIV |
Final results from a noninferiority Phase III trial testing Isentress in combination therapy showed that virologic efficacy was better than the efavirenz-based regimen at 240 weeks |
7/24/12 |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Odanacatib |
A highly selective, non-lysosomotropic molecule targeted to cathepsin K |
Osteoporosis |
A data monitoring committee completed an interim analysis and found robust evidence of efficacy in preventing fractures in postmenopausal women |
7/13/12 |
Mylan Inc. (Pittsburgh) |
Generic Sporanox |
Itraconazole |
Fungal infections |
Received FDA approval for the generic version of Janssen Pharmaceutical Inc.'s Sporanox |
7/30/12 |
Novartis AG (Basel, Switzerland) |
Afinitor |
mTOR inhibitor |
Advanced hormone receptor-positive, HER2-negative breast cancer |
FDA approved Affinitor for use in combination with Aromasin |
7/23/12 |
Otsuka Pharmaceutical Co. Ltd. (subsidiary of Otsuka Holdings Co. Ltd.; Tokyo) and H. Lundbeck A/S (Copenhagen, Denmark) |
Aripiprazole |
Intramuscular depot formulation |
Schizophrenia |
FDA issued a complete response letter |
7/30/12 |
Par Pharmaceutical Cos. Inc. (Woodcliff Lake, N.J.) |
Labetalol HCl |
Tablets; generic version of Trandae |
Hypertension |
Received its first FDA approval |
7/16/12 |
Pfizer Inc. (New York) |
Lyrica |
Pregabalin |
Generalized anxiety disorder |
Top-line data showed that Lyrica resulted in low discontinuation symptoms after tapering treatment following three months and six months |
7/24/12 |
Pfizer Inc. (New York) |
Xalkori |
Crizotinib |
Anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer |
Received a positive opinion on Xalkori from the CHMP of the EMA |
7/23/12 |
Sanofi Pasteur (division of Sanofi SA; Paris) |
Vaccine |
Tetravalent dengue vaccine |
Dengue virus |
Demonstrated proof of efficacy against dengue, generating antibody response for all four dengue virus serotypes |
7/26/12 |
Sanofi SA (Paris) |
Mulsevo |
Semuloparin sodium |
To prevent venous thromboembolism |
Withdrew its application in Europe after an FDA advisory committee voted against approval |
7/10/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Lipegfil-grastim and balugrastim |
Long-acting granulocyte colony-stimulating factors |
Breast cancer |
Phase III data showed they achieved the primary endpoint, demonstrating reduction in the duration of severe neutropenia in cycle 1, comparable to Neulasta in both efficacy and safety |
7/3/12 |
Watson Laboratories Inc. (New York; subsidiary of Watson Pharmaceuticals Inc.) |
Epiduo |
Adapalene and benzoyl peroxide Gel, 0.1%/2.5% |
Acne vulgaris |
Filed an abbreviated NDA |
7/31/12 |
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Notes: This chart includes clinical news from pharmaceutical companies as it relates to biotech products and/or fields of interest. The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||